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3/21/2024
Great. Thanks, Greg. Well, good afternoon, everybody. We really appreciate you joining us today for this update call. I want to try and lay a couple of ground rules from the start. We're going to be really collaborative on this. You're going to be able to chat with us. There's a chat on the right-hand side of your screen, and we will be looking at that and doing our best not to to be a free speech platform so please keep it respectful uh please no uh no bad language nothing obvious uh obviously kind of unconstructive uh but as a management team we really want to be as open and available as we possibly can and give everybody an update on everything we're doing and go from there um so we're going to start out with uh a uh and i should introduce the team so On the left, I don't know if it's in the same order for our viewers, but my name is Ben Sexton. I'm the CEO of Monogram Orthopedics. Directly below me on the left, there is Noel. Maybe, Noel, you can wave to the audience. Noel Knoppe, our CFO. We have our CTO, Cameron Chamais, below him. And then Dr. Yunus, our founder, who is still a practicing orthopedic surgeon. We got him out of the operating room for this call. With that, I'm going to turn it over to Noel to just mention some of the disclaimers about forward-looking statements and then jump into the call.
Thanks, Ben. Good afternoon, everybody. Just some little housekeeping here. I want to go over the forward-looking statements disclaimer with you before we get started in this presentation. We're really excited to give. As a legal disclaimer, this presentation by Monogram Orthopedics, Monogram, may include forward-looking statements. To the extent that information presented in this presentation discusses financial projections, information or expectations about monograms, business plans, results of operations, products or markets, or otherwise make statements about future events, such statements are forward-looking. Such forward-looking statements can be identified by the use of words such as should, may, intends, anticipates, believes, estimates, projects, forecasts, expects, plans, goal, target, and proposes although monogram believes that the expectations reflected in this presentation are based on reasonable assumptions there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements so no one has a crystal ball terrific thanks no appreciate it so the presentation is going to cover these five topics we're going to start with a quick financial summary we're going to get into a detailed regulatory strategy review
give you some market analysis and just an overview of where we are. We'll have, hopefully, Dr. Yunus to kind of speak from a surgeon's perspective on our product. And then from there, we're going to open it up to a Q&A. And if you have questions, please type them in the right, and we will be doing our best to get to kind of the majority of those. So with that, Noel, why don't you kick it off?
Okay, just some key points about where we are financially speaking. You know, it is our 10K reflected as of the end of the year. We had thirteen point five million dollars in cash. As you're all aware, we had a raise earlier in the year and we marshaled that cash well through the year, keeping our our burn at a minimum. We had an account receivable from that first robot sale at the end of the year of three hundred sixty five thousand and no issues with that. Our operating cash flow for the year is thirteen point five million. So as you can kind of do the math It's a burn of about one point one million You know just really quick.
I'm seeing some comments that people can't hear and can't see Can somebody in the chat just confirm that you can see? The summary financial data slide and that you can hear no Yeah, can you hear me I
Okay, good. So keep going. Okay. Sorry about that. Okay. So some people maybe have some issues, apologize for that. But anyway, so our monthly burn, you know, it's been about 1.1 million and it's been running a little hot, um, with the verification and validation phase that we've been going through. We expect that to come down a bit going into the new year. Um, know some select information to give you a little color behind that is we now have 28 full-time employees we're very product focused we have 22 in engineering and just six in the administrative function so we're very very much focused on the product development we have 26 engineering contractors 12 specifically supporting the vmv process like i said as that winds up you know at the end of the first half of the year shortly thereafter we'll be able to to cut back on that a little bit And that's that's denoted in this highly variable cost structure. That's what we're kind of referring to. We'll be able to dial back on that a bit. We have no no debt. And that's that's a big a big comment for a startup such as ourselves, you know, to not having leverage debt to get cash flow to be able to support our operations and development. Our product is a big accomplishment. And as we communicated a little while ago, we were able to finalize the one outstanding warrant that we had. And that holder actually was a early strategic investor and they converted their warrant for 1.25 million in cash. So that's kind of indicative of their confidence in our forward progress. They're willing to put in more cash. So we took that as a very good sign. We have no other warrant overhangs outstanding. So it was very, very clean balance sheet. We're very proud of that. And importantly, I'll let Ben get into the regulatory roadmap, but we expect to have sufficient access to cash to get us through the 510 approval process. So that's, I mean, those are the main points.
Well, just to say, I think what we said, no, it's not through the approval, through the submission is what we said. So we're, we're comfortable with the submission. I certainly think that from there, we would move forward from there. OK, perfect. Sounds good. So I'm going to drive into the regulatory strategy. And for those of you who are unfamiliar with some of the vernacular, we're going to explain all of it. But if you are, just bear with us. So I'm going to kind of go through the details of this to help bring people up to speed on where we are and what we're doing. So Monogram's surgical robot, we've called it Emboss. And it's a class two risk device. And class two risk devices are eligible for what's called a 510K submission. A 510K submission, for all intents and purposes, it's just FDA submission for clearance of a device. To legally sell our device in the United States, it has to be approved or not approved. The FDA's preferred vernacular is cleared for sale in the US, and that involves Uh, taking a product through a very, very intense, uh, what's called verification and validation testing process. So there's a whole development that has to take place, uh, and to kind of not bore folks on the, all of the details, but the device has to be very thoroughly tested and that testing. depending on your equivalence to other cleared predicates, may or may not require clinical data. So the way the 510 submission works, which is the FDA submission for approval, You find predicates that you think are kind of reflective of the technology and application has the same intended use as your device and it's similar in function and operation. And then you show the FDA through a formal communication process how your system works. And then they evaluate whether or not you're kind of equivalent or operate similarly to the other devices that you're comparing to. And then they look at the safety features and profile of your device and how that compares to the predicate device. And where they especially scrutinize are anywhere where there's a technical difference between the predicate that you're claiming equivalence to and your device. That's where the heightened level of kind of scrutiny goes. Those differences need to enhance safety and efficacy. And it can be sometimes difficult to prove to the FDA through non live patient testing that that's the case. So there's, uh, uh, uh, uh, typically speaking, the FDA is looking to first establish a technical equivalence, and then they're evaluating the differences and trying to determine whether or not those differences, uh, are at risk that basically can't be proven to be safe, uh, without clinical data. So the company, uh, has not been just kind of going at this alone. We are working with the preeminent, it's called a CRO, they're basically regulatory consultants that run clinical trials and provide consulting. We have retained a firm called MICRA to help us with the strategy of this submission and to evaluate our technology, evaluate all of the predicates on the market, evaluate the technical equivalence and determine whether or not the device would need a clinical trial with our submission. So we did this and in July 2022, we got a formal report from them and their conclusion was that we were equivalent to the predicates and they did not see a need for clinical testing. So that's really kind of been management's opinion as well, that we think we have enhanced the safety of our device versus predicates. I don't want to go too far into the weeds on that, but Typically, then what happens is you submit what's called, for all intents and purposes, a device description. You explain to the FDA what your device does, how it works, all of the details of the device. And the FDA, as you can imagine, with receiving a piece of paperwork that's many, tens, if not more than, I don't know how many pages it was, probably 50 to 100 pages describing your product, That's a lot of information for them to digest that. So you then engage in this process of going back and forth on how the device works, how it functions. There's questions, just really high level questions about what the product does, right? So to date, we have had three formal FDA pre-submission communications, and we have a fourth planned in April. And really, What this back and forth has been intended to do is just help the FDA, first of all, just understand how our product works, which, as you can imagine, is a pretty involved process. There's a very complex piece of equipment. It's not just kind of a quick, here's how it works. Then they understand everything there is to understand about it. So there's a learning curve and process that has to happen. And you start to present to them various aspects of your verification and validation plan, how you intend to test the system. You show them the technical equivalence claims that you're making. You show them how the safety compares to your predicate. And there's a back and forth communication. So what's been established so far with the FDA is that our system has the same intended use as the predicate, and our predicate has basically been accepted. We have, I would say it's a 510 submission that's been pretty well established. Management never got a formal written yes or no from the FDA and still haven't regarding clinical data. The FDA is typically very reluctant to give you in writing a yes or no answer before you do a 510 submission. So it's a pretty subjective process where management has to, and the team, have to try and deduce from clues and kind of, in some instances, somewhat vague responses, what the best course of action is. The FDA has not overtly said, you need to run a clinical trial. They've just given us, oh, we're, you know, areas of, we're concerned about this, and then we respond to their concerns, and there's this back and forth, and it's very difficult to know exactly uh where the fda how they feel about your device they they really do try and hold back from giving you a firm opinion until they absolutely have to which is once you submit so there's a lot of strategy that goes into this so i just want to kind of lay the groundwork to help people understand uh the goal of our next april meeting is uh you know our assessment i'll just give you management's assessment at this point management's assessment is that the risk of the fda After we submit with our current, let's call it our Gen 1 system, the risk of the FDA asking for a clinical data request after we submit, in our opinion, it's still too high with what we're calling our active embodiment. Now, it's not because the FDA has said you need to run a clinical trial. This is a subjective assessment that as a management team, we try and weigh the risks and benefits. So the goal of our next meeting is to specifically obtained feedback related to our verification test plan, as well as a clinical trial protocol that we put together that would involve running a clinical trial on a target population outside of the U.S. Now, we'll get into kind of why we're thinking about doing that in a moment, but right now we're kind of getting to the point where I would say if we were to do everything perfectly in terms of the verification test plan, it would be largely de-risked in terms of knowing what the FDA wants to see in our 510k submission. We've brought it a very long way. The FDA understands our product. They would understand the verification and testing plans and all the ways that we're going to test the system and including a clinical trial test protocol that would have the number of patients, the endpoints, the follow-up time, all of that detail. So that's really where we're going to have a very clear understanding of what it will take to submit a fully de-risked 510 , assuming the active version of the device. Obviously, as you start to go back and forth with the FDA, the reason a clinical study is of so much significance is because Monogram is an oligopoly. The orthopedic market is highly consolidated. The top four players account for 75% of the market, and the top robotics player has almost 90% market share in orthopedic robotics and has 75% market share in press fit implants. It's not easy for new market entrants to come into oligopolies. There's scarcity of capital, and these large companies understand this. So getting funding for a clinical trial, which can have a significant cost. Now, it's not an astronomical cost, but it's a significant cost. To give you some framework for that, our CRO estimates that the cost to run a clinical trial would be somewhere in the order of $30,000 to $40,000 per surgery, and that we would need to run on the order of 90 to 100 surgeries with three to six months of follow-up, depending. So that would give you some scale. It's not so much even the cost of running the clinical trial itself and paying for those surgeries. The big challenge is the number of sites that the FDA would request. if you let's say had a three site trial you need to have inventory for three sites and the biggest challenge that we have in our industry is the lead times to procure implants is significant this is why we exist we want to have a just-in-time 3d printed implant model but in the world we live in now with generic implants the lead times are very significant they can be in excess of eight months they can even be up to a year if you imagine for a small company you have to have the working capital to fund all of that implant inventory. You need to have robot inventory and then you have to obviously fund the operations while the clinical trial is running. So it becomes not an astronomical cost, but a significant cost in a market that is an oligopoly where there's a general adversity to new market entrance and where funding can be expensive. So That's a long way of saying we don't want to do a clinical trial if we don't have to. And so as we started to get a feeling that we may need to do a clinical trial without certainty, it's still a gray area. We could still submit a 510 and say we think we have good arguments, but we don't think that's prudent. We have been working on some making some technical differences to our system that we think could significantly enhance the safety profile and equivalence to systems that are on the market already. So we have kind of, we're putting a package around what's called our active system is. We're gonna know exactly what the FDA wants to see. And then in parallel, we're going to have another version of the product that we are working on and very likely going to be the one we submit for approval that we think really does not meet the threshold of a clinical trial. And they will say that that's our opinion. Maybe the FDA would see it another way, but we've had enough meetings with them where we think we understand where their concerns lie and which I'll get into what their concerns are largely. And I don't want to characterize everything they've said. Maybe there's other concerns that we haven't identified, but these are the ones that we think are relevant. And so I'm going to jump into that next. So where do we think the main problem lies with the FDA's sort of concerns about our product and the technical equivalence to the current state of the art? We think it mostly relates to what they characterize as active versus semi-active. So on the left there, you can see two semi-active systems, Mako, which is owned by Stryker, and Veles, which is owned by J&J. And what you'll notice is that the surgeon is holding the saw that is mounted to the robot arm. And the surgeon is responsible for moving the saw during cutting. With the monogram system, the movement of the saw doesn't depend on force applied by the user directly to the cutting tool. So that's more of an active embodiment. This is really what the FDA has concerns with. Now, I will say, I'm going to jump into this now, we had very good reasons for designing the system this way. We actually think that our embodiment potentially enhances the safety profile of our device. So for example, with both hands free, the surgeon who's the most experienced and trained user of the device and the most trained person in the operating room now has two free hands to hold retractors and protect soft tissue. So we think that's a pretty significant enhancement. You don't have any surgeon fatigue because the surgeon isn't holding a trigger and trying to wrestle a robot. They're focusing entirely on where the blade is cutting. And there's a lot of other things we can get into, but be it as it may that's that's kind of the perspective that we are working with the reason we designed an active system really was some of those things i already said we believe that it would minimize the learning curve we believe that it eliminates a lot of the surgeon skill required with cutting surgeon fatigue our goal was really to enable complex bone preparation so milling for patient-specific implants minimize the disruption to the workflow We also don't think that it's a perfect safety feature for devices that have virtual boundaries for the user to be pushing into a virtual boundary. You know, a lot of times those virtual boundaries are protecting soft tissues, and we don't think it's kind of a perfect system to be pushing into a boundary that is protecting soft tissue. And really our goal generally is to have a robotic system that is multi-application. And we believe that a more active paradigm is more scalable for that. So that's some of the design motivation. With that said, there's limitations to an active design that we'll get into, but I'm not going to get into the weeds on that. This is highly proprietary. We're just not going to talk about how we're changing our system. But we basically believe that we can modify our robot to basically be closer to the predicates that we're claiming substantial equivalence to. So we think the devices on the market that were more similar to are Mako and Bellis. Bellis did not have to do a clinical trial and they claim substantial equivalence to Omni, which is another system on the market. We think we have pretty strong equivalence arguments. So for example, if you just look at the Bellis 510K, they describe their system as a motorized instrument controlled by the system automatically positioning the resection plane within the plan plane for the bone resection and maintains alignment through dynamic compensation. So to make a long story short, uh, we, we believe that, uh, we have some very, very, very strong equivalence arguments with that system. Uh, it is foot pedal operated for movement of the arm between resection planes, and we can, we'll leave it at that. Uh, so there's, uh, the company has decided that the technical differences of concern relating to active versus semi-active can be addressed with some technical tweaks. And that's what we're going to be doing. And we believe that these changes will mitigate the risk of a clinical data request. So we think that's really positive news. We announced that in the 10K, and I'm going to get into a little more detail on that. But before I do, I just want to talk about potentially some benefits because There is certainly ways that these technical improvements potentially improve the system. So specifically, one of the barriers to utilization of robots is the time it takes for the robot to actually do the cutting. So we believe that our changes could enhance the feed rates of the system, and we've proven that to be the case in cadaveric testing. Dr. Yunus was here actually last week for a lab, and he can speak more to that, but There are some improvements. So I don't want folks to think that we're just purely modifying the system so we don't have to do a 510 , not a 510 , a clinical trial. There are actually ways that we think this will make our device even more attractive to surgeons. So I just want to kind of help explain where we are now. This is might be a little bit tedious, but I think it's really important.
So monogram is kind of where I noticed it's a little bit smaller production should have made that a little bigger.
But monogram is kind of it says monogram is here and it's circled the design verification phase. So we are in the thick of the design verification phase. So there's approximately 60 hardware and system test protocols that we're working through and then another over 100 software test protocols we're working through. And these are all tests to basically prove that the system is safe. The goal is to be largely complete, and I say largely, and that's bolded, complete with the verification and validation of what we've said is in the first half of this year. So we're pushing very aggressively on that. We're making very large good headway uh is it possible for it to that timeline to slip yes certainly uh and I'll get into what would make it slip uh the biggest risk really is that we're a pretty small team and and working very hard and most of this is in our control but there are some of it that not I'll get into that and then uh we are in parallel preparing the 510k so our quality and regulatory team is working very hard to have everything ready so that once we finish the verification and validation testing, we would be able to submit that to the FDA as quickly as possible. So our target that we've set publicly is for a submission in the second half of 2024. And what we've said is we believe we have the capital on hand for that submission. And the reason I corrected Noel is the Right now the time for the FDA to respond is on the order of between five and six months. That's kind of their turnaround time for clearance or approval or rejection of a 510 . So that's variable. The FDA, that's out of our hands. If the FDA took longer, obviously we would need to account for that. If they took shorter, that's great. But this gives you some idea of kind of where we are. So we, The biggest risk, I'm going to just kind of talk to the verification and validation. So this is what we have to do before we can submit a 510K. I'm just going to get into some of the big ones. The biggest risk is, and we have Cameron on the phone who's had many kind of sleepless nights over this, is what's called ISO 6601. So this is a kind of an industry gold standard for safety. It's a third party that basically is and certifying the safety of your device. It's not a requirement for the FDA, but it's a very, very, very strong and good, nice to have. And we think that it greatly enhances our 510 submission to have this. The biggest, most risky part of this that we've already passed was radiating conductive emissions. So we pushed very hard through that. The team, I can't say had many sleepless nights getting through that, but the pace at which we cleared that was phenomenal. And so we're halfway through that, and we expect that that's going to be done. And the next piece of it, we have more confidence in. We've been able to de-risk the remaining piece with internal testing. The radiated and conducted emissions is very hard to simulate in-house, but the remaining tests we've already tested. We're pretty confident our system's good. There's a huge amount of paperwork involved, but we are pushing really hard on that. but that is a risk if that if that that's a third party and if they are slow there's not much we can do about it but we do think we're on on track there and we're pushing them very hard um you know the other thing is just kind of resource constraints uh we have a lean team we've been running it very lean and uh that that's always you know a risk if you have uh you know uh key people get sick uh that hurts us but i think we're in a good spot um We human factors, which is part of the verification requires a minimum of 15 patients, surgeons, and surgeons are very busy. We have identified the surgeons for the most part that we're going to be working with and we're getting them booked in on aggressive schedules, but it's tough. Surgeons have very busy schedules and sometimes things don't work out. We think we have plenty of cushion there, but I do want to flag it as a risk. And then again, you know, This is what we've said. These aren't guarantees. We think we have a pretty good shot at it and we're pushing to do it as aggressively as possible. And of course, we think that it's a very meaningful milestone for the company to submit a 510 with what we think are very, very strong equivalence arguments and what we think is a very, very attractive safety profile to the FDA. So we're not just going in with a risk of that. We want to mitigate risk every possible way. So what we're doing in parallel, as I said, is we are preparing to launch a clinical trial outside of the US. This is well underway. So we expect, hopefully, we can make some more announcements in the near future about this. But we are currently targeting about, we need to do just to make the statistics work out, about 88 surgeries at three sites. And we have, we're looking for a 25% safety event rate reduction. We have identified the endpoints we're looking for. They all largely relate to iatrogenic injury. We're pushing for a six-week follow-up, which is pretty aggressive. We've already identified the sites. We've already identified the CRO. We've identified the PIs. We've identified the distributor. So this would be at a significantly reduced cost to what it would cost for us to run a clinical trial in the United States. So the plan is if we submit the 510K, which we think is a very, very strong 510K with very good equivalence arguments, but if the FDA were to come back to us and say that they had an unfavorable view of our submission and would like to see clinical data, Our plan is to have it very well far along in parallel, kind of as a belt and suspenders where we could just say, okay, well, here it is. And in April, we hope to fully de-risk the FDA's view on the clinical data submissions. I hope that makes sense. We're really trying to have optionality. And if the FDA were to approve the 510k, It's still fine because first of all, the cost to run this trial is not very significant. I mean, certainly there's cost there, but it's much less costly than in the US. And then we could use that data for post-marketing, post-launch marketing in the United States. And we could look for other endpoints like learning curve, accuracy of our system, surgical time and so forth. And then we would have the added benefit of being able to launch OUS in what we think is a very attractive market. So it's kind of a win-win in killing two birds with one stone. So I just kind of want to give folks a little bit of a view on how we're thinking about just the market generally. And Doug, this is where I'll tee you up in a second here, but when we when we started this is like very simply what we saw the market opportunity as if you just look at uh at the market dynamics today um there is one company that has 89 market share in orthopedic robotics for knees and 75 uh market share in press fit knees now in in anybody's definition of a monopoly this is what a monopoly looks like and our investment thesis was is very simple We think that not all, certainly Stryker is a well-diversified business, but we think that Mako has added billions of dollars of value to Stryker. It's reflected in how the stock has performed. It's reflected in the market performance of Mako versus everyone else. And so we think there's a very simply an opportunity for a compelling robotic system. And we really are thinking about it in a very simple terms. That's what we see as the opportunity. We think there's an obvious market. It's a very high margin market. And we think that our investment thesis going in was that this would be valuable to somebody. Could we be wrong? And could this be a complete not valuable? Certainly, but we're not, I don't think that's where we as a management team are today. I think we have a very compelling product. We think it's competitive with the current state of the art. We think that it enhances on the current state of the art. And we certainly think that with future upgrades that Doug will get into, like the M-Vision navigation, Cameron can describe as well, it will be probably a pretty significant improvement over time. So I'm just going to play this video, Doug. It's like a two second video here. And I want you to try and explain this because I think it really is sets the stage for how early this market opportunity is and how significant it could be. I'm going to play this video. So a lot of the world hasn't moved. I'm going to press pause here. This is from a It's on our site. When we released an update on Envision Navigation, we had a Q&A, and this is Dr. Adler describing basically why robotic adoption has been slow. And this is a big part of investment. So I'll play it, and then, Doug, maybe you can comment on it.
Sure. A lot of the world hasn't moved away from the mechanically aligned knee yet.
That's it.
Well, that's it. That's exactly it.
That's exactly it.
It'll take a little while, but it'll get there.
Yeah. So, Doug, what does that mean? I want to make sure folks understand that.
Yeah. You know, I want to be careful to stay out of the weeds. So, Ben, just pull me out if I go in too deep. But, you know, we... We've been doing knee replacements for 50 years with mechanical instruments, basically, you know, that look like the kind of instruments you would use to build a chair. You know, they're really just jigs and saw guides and that kind of thing. And, you know, largely because and, you know, you can imagine that's fairly crude. You can't you can't make a cut that's, you know, three degrees or two and a half degrees. You know, you can kind of cut it right angles. You know, you can see that and judge that with manual instruments. But you can't really make these little fine tuned cuts. And so, you know, partially because of the constraint of the way we've done these for the last few decades is. every knee gets put in essentially straight so that what we call mechanically aligned knee. And the problem with that is that very, very few people actually have their knees lined up that way. And so about 20% of knee replacement patients don't love their knees. And so a few years ago, probably about 12-ish years ago now, there was a move to align people's knees more the way that their individual anatomy is because we're aligned in all kinds of different ways. You know, some people are a little knock-kneed, some people are a little bit bow-legged, and there's been more and more research looking at kind of the spread of how people are aligned. The problem, one of the problems with giving people back their kind of the way that their knees should be aligned is Is that to do that with manual instruments is is hard. And, you know, most surgeons can't really do it. And so there's a very strong movement in this direction to kind of get people to to kind of align their knees. We call it personalized alignment. And so there's a huge opportunity for technology. to make it more possible to get there, to get to those targets. The current technology platforms that are out there, they really weren't designed for that. They were designed to do a better job of kind of giving everybody that straight knee. And they do that. But the problem is, is that it hasn't, you know, giving everybody that perfectly straight knee and hitting that target every time, it hasn't actually really moved the needle on how well people do after a knee replacement. Even with robotic knees done with the kind of traditional alignment, the same 20% of people are still not super happy with their knees. But if you use the right robot to kind of give people back balance, their own anatomy, all of a sudden there's data coming out saying that they actually do much, much better. And you have 95% plus very, very happy with their knees. So we think that there's, we're designing a system that really is looking at where the puck is going, as Ben likes to say, and that is at personalized alignment. So we're designing into it the ability to resurface the joint, to restore their patient's anatomy. It's one of the reasons we think having a CAT scan is important because you're trying to resurface their knee. And without that CAT scan, there are a lot of systems out there that are imageless that don't use a CAT scan. We think a CAT scan is important as we move more toward personalized alignment. So anything else you want to say about that, Ben?
I think you nailed it, Doug. You know, I'm seeing a couple questions that relate to, you know, are we basically downgrading our product to appease the FDA? I would say definitively no, right? In anything in life, in any engineering, there's trade-offs, right? So the benefits of a fully active system, we think I articulated those. There's also benefits to the current state of the art. And so what we envision is a system that can do both. So we want a system that could be active when it needs to be active and is most efficient to be active. And we want a system that has other modalities when it suits the surgeon for the other modalities to be working. We do not believe everything we do at Monogram is for basically the benefit of the patient. If we didn't believe that we had a compelling product, I don't think we would be here. I mean, Doug, you used it on this weekend. Do you think it's without saying too much? Do you think it's a downgrade?
No, because, you know, what we've done is we've kept the safety features. We've kept the kind of the pluses of the active system. We've kept all those safety features, the hand guided bit of it. just allows you to go faster, which is ultimately a premium. And as Ben was saying, you know, we there are some things that you want to be active. For example, you know, our ultimate vision for the company is and the reason it's called Monogram. is that we ultimately think that pairing a robot with custom 3D printed implants is where where things are going. And custom milling, for example, where you swap a saw out for essentially a Dremel or a burr. For custom milling, we think active is a much better way to go for that part of it. We want to keep the active bit for that type of thing. For cutting with a saw, hand guiding definitely helps.
If hand guiding is the way we go, semi-active is just kind of broader. We have a different embodiment that we think enhances the equivalents, but we think we ultimately will have a more robust product. And just kind of to recap the critical design features of our product, and this is why we're here. So when you look at the current kind of state of the art, right, every system basically follows these workflows and Maybe, Cameron, you can talk a little bit about our novel navigation that you've developed.
Specifically about the next gen or the current one?
M-Vision.
Okay. Yeah, so one of the major steps in joint replacement is basically called registration. Registration is a process that allows the robot to know where the patient's anatomy are. That means where the bones are, you name it. So currently the All the robots in the market, they use a technology called optical tracking. And what that means is that we place a series of markers on the bone or on the anatomy that we want to track. And then we run some algorithms to register the bone. We basically tell the bone where the bone is. And then from that point on, we track those markers on the bone. That's how we know where the anatomy of the patient, all the bones and all the different issues are during the procedure. This part of the workflow takes time. There is that we need time to expose the bone. We need to mount those markers on the bone. And then we need to register those the patient to me, to the to the markers and so on, so forth. And these procedures entire all these parts of the workflow could take around 15 minutes with installation of. the markers all the way to the actual data collection and registration. It could go between 15 to 20 minutes depending on the system. So the technology that we have developed here and we're now productizing it basically removes that step. In a matter of a couple of seconds, we basically register and start tracking the bull. And so what that means is that 15 minutes of the procedure, 15 to 20 minutes of the I mean, based on the data you see here, it's more than that, but I'm just being harsh on ourselves. That step is basically entirely removed. What that means is that 15 minutes of our time, which is very expensive, is removed. In addition to that, all the consumables and all the navigation instruments that we need to do the current tracking and registration, they are also removed. That is, again, a major cost saving procedure, but also for all U.S. market. That is basically the game change, a game changer, not only in the U.S., but even more so for the U.S., because consumables tend to be way more expensive when the currency is exchanged. No. Yeah. So we're very excited about that.
Perfect. Thanks, Cameron. So kind of just. really recap the design features. Uh, so we're innovating on the surgical approach and registration. That's not gonna be in our gen one, but it's gonna be, the emboss is gonna be upgradeable to envision. And the idea here would be as Cameron said, no, uh, uh, no point based registration and, and hopefully a very streamlined navigation. Uh, we have, uh, We think it enhanced certainly over some of the state-of-the-art solutions with, we think, improved joint balancing. This has been a huge focus for the company. We think this is a major benefit of being a CT-based system is joint balancing, and specifically as you get to more patient-specific techniques, our system accounts for things like tibial rollback and some of the biomechanics, which is not a trivial thing, And then the bone preparation, we think we have a very high efficiency mode of removing bone. But we have enhanced safety. And our vision, we have a clear M-Press implant line that's ready to go. So we have state-of-the-art cementless implants that are already approved. And then as we are successful, our plan is to scale to other applications. Our plan is to scale to patient-optimized 3D-printed implants. that'll happen in series. So what we've said is we're starting with the M-PRESS implant line. The tibial component will be replaced with a novel tibial component that Doug has been spearheading the design of. And then we would look for further optimizations from there. And then finally launching OUS, we think is also a pretty attractive I'm not sure. I think that might have been a remnant bullet. Basically, we believe that the solution we have, as Cameron said, makes sense to the U.S. as well from a consumer's perspective. Just in terms of how we're thinking about what the company, just looking at comparable company analysis for predicates, or not predicates, but comparable companies in the space that got approval. uh you know there's not a lot here it's a very consolidated market there really haven't been a lot of good comps i think we could argue why monogram is different than any of these and why the we think that uh the value of monogram uh these metrics may not fully reflect the value of kind of what we're doing here and how disruptive what we're doing could be but this gives you some idea of where a company like Monogram could be post-approval, but certainly not a forecast or make your own determinations of what you think Monogram could be worth. But these are the metrics that bankers and so forth generally look at. And now I just want to recap our investment thesis. So our vision is to commercialize an orthopedic robot that advances the standard of care in orthopedic robotics while addressing the economic obstacles of orthopedic robotics today. So when you look at robots on the market today, we don't see any robot on the market today that increases throughput. So it increases surgical time, it decreases surgical time. And we see every robot on the market today basically requires incremental consumables. So you're adding costs, you're adding time, and then the clinical benefit for any system that doesn't really do personalized surgery very well is sort of, I would say kind of marginal at best. You can probably do a mechanical knee replacement with manual instruments more accurately than you can with a robot. So the value proposition of robotics really hasn't been fully realized. And our vision is to create a robot that solves economic problems and clinical problems. So how do we solve the economic problems? Well, we're going to try and make a robot that's faster. How are we going to do that? We're going to use technology like Envision, where we get rid of point-based registration and hopefully get rid of all of the setup, placing large arrays. We have very, very efficient cutting. then we're going to have a a system that doesn't hopefully doesn't require any consumables in the navigation so if you imagine kind of getting rid of the incremental consumables and then you think about a system that can scale to other clinical opportunities because it is such a an incredible piece of hardware right this is a seven joint robot arm uh it has a lot of dexterity uh We can mill hip cavities in prototype versions of our design in simulated surgeries. You think about minimally invasive surgery, having a system that could be active when it makes sense to be active or semi-active. Really, what we're envisioning is one robot for the operating room, training, servicing, sales, all synergistic, basically a Trojan horse that if you get it into a hospital, now your spine group has something to sell. Now your knee group has something to sell. Now your hip group has something to sell, your shoulder team. That's really the vision of the company. And then over time, we have very compelling personalized implant designs, and we plan to upgrade the impressed implant line to, uh, to more and more enhanced, uh, implants that we think will address the, uh, basically the working capital burden. Uh, I think that's, that said, we want to close with this slide and, you know, first off, I want to say something cause I, I, you know, there are people that post, uh, online and I just want to tell you as a management team, we do read those comments. So, uh, If you want to communicate with us, we do see where people are frustrated at what they're saying, and I want to say a couple of things right out of the gate. We're not happy about where the stock is at. It doesn't make us feel good. We are competitive. We believe we have something compelling, and that's not something that makes us happy to see. I'll say to that as well, none of us as a management team have sold a single share. I haven't sold a single share. Noel hasn't sold a single share. Cameron hasn't sold a single share. In fact, Cameron, I think you bought not too long ago. You participated in the IPO, I believe. Doug hasn't sold a single share. So we're all in this. We're not selling. And this is kind of an interesting just sort of anecdote, but if you go back and look, You know, Mako Surgical, their stock was down 75% six months before Stryker bought them for, you know, $1.6 billion. And when you think about how much value that technology has added to the Stryker portfolio, I mean, it's pretty remarkable. So, you know, our comment to people who are panicked is sometimes the market is right. It certainly is in the short term, a voting machine on sentiment but we're here for the long term uh we're not selling uh and we believe in what we're doing and we're here to stick it out and do everything we can to bring this technology to market and uh i you know if the if the stock goes down to one penny or if it goes to 10 bucks we're here for the long term ultimately this is about technology We're trying to do something in the orthopedic market. This isn't oligopoly. We think that there's been a scarcity of innovation in this space. We feel like it's to the detriment of patients. And we're actually trying to do something and make a clinical difference. And that's what drives us. What doesn't drive us is the stock price going up and down every day. What drives us is how do we make a technology solution that is going to enhance patient lives. That's the fundamental motivator behind our company. Everybody who's here has the same passion for patients. And so that's really how we're thinking about it going forward. And with that, I want to open the floor for questions. I have seen a number of questions here that we kind of maybe want to tap into. I'll put them under the screen. I know folks have been asking a lot of questions here. see here uh so let's put one from greg so greg says i worry about the lack of capital to move it to the end just doesn't seem like you'll have enough to complete the program so you know greg what you have to understand is um when you're when you're a startup company uh and somebody says never uh the team you're looking at here is we're not quitters like that's uh you're looking at some of the we are very very very very dedicated okay uh i worked at monogram for two years without making money And if I have to do that again, I will. This is not going to die. It may die. It may fail. We may run out of money. Fine. But I refuse to let this thing die. If it does, it's going to be a massive disappointment to, I know to me personally, to the team, it's going to be devastating. I know to Doug. I know Doug's had to sacrifice a lot. We may run out of money. There may be people who don't believe in this and don't want to fund it and want to see us fail. And the only way this would die, in my opinion, is if this isn't actually a good idea. If the product we're developing does not help improve patient outcomes, if it's not a good product, if the market doesn't want this product, then it should die. But as long as we believe that this is actually going to make a clinical difference, as long as we believe we actually have something, I think the team, I think we're going to refuse as much as we can to quit. Now, I'm not saying that we can't fail. You know, we have a going concern from the other. I think that actually got cleared. But even if it even if we did have one, there's a lot of risk here. we might fail. It's not a guarantee of success, but what I can guarantee is that we really want to see this be successful, and our motivation is more than just to make money. We care about this technology. I don't know if I speak for everyone else, Doug. If I speak for you, we're not okay just seeing this fall away. I think there's a market need that we are trying to address so yeah you know speaking of capital we do have the capital we think to submit the 510k right that is a major catalyst right so once you have a product that's submitted for clearance and you know then that really does change the game in our opinion So, yeah, Doug, go for it.
Yeah, no, I think, look, you look at the market and you look at the slide that Ben showed before where Mako still has essentially the monopoly on the robotic market, despite the fact that one of those one of those robots on the list actually came out before Mako and has as essentially nothing. So. What happened was, you know, Stryker bought Mako. It's been extremely successful at driving sales of implants for them. And so there was a just desperate drive in the market to get a robot on the market. And it was kind of cynical. It was like, well, just get a robot out there and surgeons will use it because a robot's a robot. And that turns out not to be true. Like surgeons know what helps them in the operating room. They know what helps patients. And, you know, they have largely rejected these other robots that were kind of brought on to the market. And we're looking at that. I mean, I'm a surgeon. Like, I know what helps me in the operating room. I know what my colleagues are talking about and what helps them. And so we're really, really sensitive about not just putting another robot on the market and thinking that surgeons will see it as equal to everything else that's out there. That's just not the case. So we are we are working on a product that is really going to, as Ben said, drive. better patient outcomes, but also be a product that a surgeon wants in their hands, a product that actually lowers their blood pressure, makes their day go easier and faster. And and that ultimately is how these things get adopted and have staying power. So.
Thanks, Doug. Yeah, so again, there's risk, capital is tight, but we think we have a plan to execute and we're focused on execution and doing all we can. So Cameron, this one's for you. Will the software be upgradable to add an AI element when AI technology matures some more? So maybe you can talk about AI
Sure. Yeah, so our software already has AI components integrated in its pipeline. We extensively use them and that's one of the benefits of our system where we don't need like an individual to sit back there and just generate whatever data the robot needs to operate in the OR. We already have those. But yes, our software is I could say not only a software, but also our hardware is designed from the ground up to be upgradable and to be modular and to support multi applications. Just imagine how many years we have spent developing this robot to get it to the to the level of maturity that it has right now. Now, imagine if we wanted to develop another robot for, let's say, sparring. Then we had to go back to like to the first step and spend it like you can spend around like five, six years, four years, however many years to get to where we are right now. you know, develop a spine procedure. But our system is not like that. Our system is already upgraded. In a matter of months, we can convert this for a different application, integrate AI modules in it, and so on and so forth. Like the MVision that I mentioned, that's very much AI driven. And or engineers here already run it on our system for their proof of concept or their prototyping and and all the other for for the current version that we have in-house. So the answer is yes, it's already you already has elements and it's fully integratable and the software is fully modular. So any even any component that currently any module that is currently potentially not driven, or when we have the AI-based version of that, we can easily replace it.
There's so many places in our pipeline and in our technology where AI can be plugged in. Cameron just touched on some of the technical stuff. But even on the clinical side, you know, I was talking earlier about just aligning knees and figuring out, You know, if everybody doesn't get a straight knee anymore, like what's the right target? And there's a lot of discussion about that. Like what where should you put an individual's knee, if not like in this straight line that we've always done? And I can really be used in that sense to figure out like to drive. Where do we you know, looking at a particular patient, where do we what's the right target for that patient? I think the, you know, it's, it's, it's very, it's a very rich environment for using AI in that sense. And something that will get better as we do more cases. And as the technology matures, as we get more CAT scans, more imaging, more surgical data, et cetera, really exciting, exciting opportunity.
Yeah. This is an interesting one from Stuart, you know, a little cynical, but, you know, he says there's, there are people who want to see it fail. They have deep pockets and, then they pick up the IPA in a fire sale. Stuart, I know I'm an optimist. I know Doug is an optimist. I know Cameron is too. We really believe in trying to, we believe that the standard of care in orthopedics, that if you look at the market, and this is true of any oligopoly, what happens with oligopolies it can happen is you can really have two things that i think are not positive one is you you really basically have no new market entrance right it's very difficult for new market entrance and you can start to have in our view over time a complacency where uh the uh these incentives to actually try and change things and make things better and try and really push the ball, the economic incentives start to not be there anymore, right? Is there really an economic incentive to take away the barriers to entry for new players? If we actually had just-in-time implants, is that really what's... best for uh incumbent players that already have billions and billions of dollars to to fund working capital so uh that's true but on the other hand what we care about and why we're doing this is patience so we fundamentally believe that and and there may be many people who think what motivates us is uh you know we're just trying to get rich or we're just trying to whatever And I can tell you right now that that is not the motivation of this company. The motivation of this company is to try and advance the standard of care for patients. That's really why we're here, what we're trying to do. And failure to me would be we fail to develop a product that does that. And every decision we've made from an engineering perspective has been to try and make things more accurate, make things faster, make things easier to use, drive utilization of robotics. We believe that the utilization of robotics will help patients. And I'm going to stick my neck out one level further. Every robot company that we're aware of on the market has tried to be target agnostic. So robot companies have basically tried to say, okay, surgeon, do whatever you want to do. If you want to do a mechanical knee, do a mechanical knee. If you want to do a personalized knee, do a personalized knee. We're just here selling an instrument. That's not the view we're taking. We actually believe that clinically speaking, we have very strong biases about what a knee replacement should be like. And our goal is to try and drive the science there to prove it. Now, I'm not saying we're right, but I think that it's imperative that technology companies in medicine actually try and figure out what the best way to treat a patient is. And don't just sort of keep doing the status quo. And I think that's part of what frustrates people about Monogram is that we are biased. Now, certainly our tools, somebody can take our tool and do a mechanical knee. That's what they want to do. But we we'll be researching we will be trying to change how people think about knee replacements and we will be trying to help answer the question of what is the best target because ultimately why we're doing this is not just to make a tool that cuts bone but we want to have a tool that actually helps drive patient outcomes so does that mean that somebody's going to try and kill us sure but i do believe that you know if the mission is is there and genuine and strong enough can somebody squash it sure but we're highly motivated to try and do this for the right reasons and we'll we'll see what happens and hopefully hopefully that prevails because I do think that these companies that we're competing against I think they do care about patients I just think it's sometimes you know being so large can be it can be difficult but i do think that that exists in the orthopedic space where i do believe there's a lot of people with integrity where that's what they want and i think that a company that cares about that i do believe that it actually does resonate so i hope that hope that helps how we're thinking about it i just want to add um ben if i may yeah of course go for it
So I want to talk on the behalf of the engineering team, which is right now pretty much other than a couple of people, most of the company. We are very lean. I can tell you, and Ben is my witness, we work around the clock. We work till 4 a.m. every night. We wake up at 7 a.m. back to work. And that's not the thing that we do one day or two a day. That's basically our life ever since we joined Monogram. We don't work like this out of fear. We work like that because we love what we're doing and we love what we're developing. You know, the example I always give, you know, I'm Persian, I'm from Iran, you know, the example I always give is Alexander the Great, you know, when he started, you know, the Persian kings were laughing at him and see who wrote the history, right? I just limited to that.
That was good. That was deep. We're getting sentimental on this video. Yeah. So here's just another question from Mark. How do you plan to raise money in the coming months before you can go to market? So this is an interesting question. As many of you know, we're crowdfunded. We've been crowdfunded all along. I do think there have been opportunities for our crowdfunded investors to get out at accretive prices. I certainly would have hoped that it would have been higher for longer and whoever wanted to get out and make money could have, uh, whoever invested in our crowdfunding and is still with us, you know, unfortunately you're here for the long time, the, uh, the long haul, you know, um, some, sometimes there's an expression like, uh, you started to make money, but now you're here for the tech. Now it's become a long-term opportunity, uh, right. With the prices where they are. Um, When we have gone out to institutional investors, they really have wanted to see things that we couldn't actually answer. So we didn't know how many patients the FDA was going to require for a clinical trial because we hadn't submitted a clinical trial protocol. And we hadn't submitted a clinical trial protocol because The FDA hadn't definitively and they still haven't told us whether we need to do a clinical trial. So why would we submit a clinical trial protocol to them if we don't need to do a clinical trial and bias the whole discussion? Right. So there are some things that have taken time that have been difficult for us to fundraise around. Right. Because if you don't know what the budget is to do something, it's hard to get it funded. But now a lot of these things are getting de-risked, right? So we talked about the discussion we're having with the FDA in April. That's going to be a massively de-risking thing where we now have clear answers for all of that. We're planning to submit our 510 . That is a huge milestone. That has been a massive, massive amount of work. there are hopefully we're going to get a clinical trial approved outside of the US. That's a very significant milestone. So now I think we're getting in an improved position where we can tell the story and hopefully we can find investors that believe in the opportunity just as much as we do and resonate with the mission of the company, which is to try and improve patient outcomes. That's really why we're here. we have, and I'm just going to float this. There has been some discussion of, you know, should we even look at going back to, you know, one of the things that's really interesting and it's been a problem for us, but it's a problem that I, I love and hate. So one of the problems we have right now is our stock doesn't have a lot of volume and that's because we don't have a very large float. And the reason we don't have a very large float is because lot of our investors in fact the majority of our investors and i i haven't pulled this like as of the kind of recent price action but a lot of our investors uh invested because they actually want monogram to succeed because they care about the technology uh and they were really just almost like a gofundme they weren't concerned about the returns on the stock. They were concerned about this technology getting to market. Our average investor was 65 years old and actually cared about the technology. You know, and anytime we do any kind of communication, we're inundated with emails from people who actually care about the technology. So we have an audience that cares about the technology and is interested in more than just kind of maximizing to the very last penny returns. And as a management team, we have been thinking about, okay, well, maybe there's an opportunity to, at these levels, give access to people who care about the technology, kind of, you know, one more opportunity with hopefully a lot of the creative milestones. We're going to talk about that more that's in discussion, but just something to have in your minds as we continue moving forward. So I want to make sure that we keep getting to questions folks have. So OK, here we go. Why so much engineering now? I thought the product was submitted to FDA and kind of frozen until approval. So Mark, we have not yet submitted to the FDA In fact, the engineering on this product is largely done and has been for a long time. Cameron can speak to that. Right now, it's just going through all of the testing that's required for the submission. So you have to prove to the FDA that your product is safe and effective. And that is not a trivial process. We're making a lot of headway and we plan for that to be largely complete in the coming months. All of the engineering or the predominant engineering is on the mVision navigation, which is our novel navigation technology. I think there's been a lot of confusion and part of it is when we say, you know, 510 , and I do see there's some people who think we have been misleading about the timing of the clinical trial and so forth. We have never been misleading about the timing of the clinical trial. We've always said, that we are discussing with the FDA. We are trying to determine whether or not clinical data would be needed. And there was a lot of uncertainty around that. And in fact, we talked to regulatory consultants who still think, well, at this point, management has a strong feeling that it would be smart to have a clinical study with this embodiment. But it's never definitive. The FDA doesn't give you definitive answers. And the time it takes to get to a point of granular discussions is very time consuming because every time you submit to the FDA for a response, it's 60 days. for them to get back to you. So you're talking about a pretty tedious process. But, yeah.
If I can add, Ben. Yes, sure. Yeah, so if the question is why the engineering team is big, I would say the engineering team is actually relatively small compared to all the competitors that I'm aware of. You know, we are actually at least one order of magnitude smaller in terms of size. But if the question was, why do we do so much engineering work? Because it really takes so much engineering work to get the surgical system of this scale to the market. And per Ben's point, yes, no, we have not submitted to FDA yet.
Yeah. So we got a question here about analyst coverage. Investor Road shows strategic investors. So, you know, we we uh recently presented at the canaccord conference um a lot of it is kind of what i said right is um institutional investors um are not as inclined to take risk right uh they they want to know what the budget is uh what the milestones clearly are what the timelines clearly are and so forth right so um we're now getting to the point of having that very very clearly defined for us. And we think that that's going to be helpful for them. Now what's frustrating is the stock really kind of going down and becoming less attractive for fundraising. And so we are not interested in diluting our shareholders. We really want folks who have been with Astoria was a long time to thrive. So it's a really delicate balance of trying to move the ball forward as far as you can, but obviously de-risking those milestones. So what we have said is we think we're in a good spot to get through the verification and validation. We think we're in a good spot to submit a 510 . We think those are pretty accretive milestones. And then discussions are ongoing. And when it comes down to the panelists' coverage, That's something that is difficult to control. We have talked to numerous investment banks and we have retained investment banks. We did not like the deal flow so far that we were seeing, but hopefully that improves as we kind of continue to move the ball forward. And generally speaking, initiating a relationship with an investment bank and working with them is helpful to analyst coverage. So the two are largely tied together. Okay. So we got maybe, maybe we'll do five or 10 more minutes here. Any other questions for the team? Okay, this is a good one. So I think this relates to the clinical trial, but it's helpful to just talk about overseas. So there's a lot of synergy to the OUS clinical trial that we're running. What we've said is we've identified the CRO, we've identified the distributor, We've identified the PIs. We know we will be using basically the IMPRESS implant, a cemented version of that. So we think that we will require less inventory and that it'll be kind of a lot more efficient to run a clinical trial with U.S. for strategic reasons, it's not helpful for us to say more. Uh, the, uh, the Indian, you know, when we talk about patients, right, there's obviously a huge need in the United States, but, uh, Cameron and I had the opportunity to be, uh, in an operating room outside of the U S not too long ago. And what I can tell you is that there is a very serious need for technology in certain markets outside the U S. Um, and, uh, think this could do a lot of good for for humanity to have products that basically make surgeons better at their jobs out there so you know we're getting we're getting some comments about you know more regular updates and and um you know we we've tried to have a balance of making well-informed updates. There's a lot of factors that we hope people can be aware of, right? We are an early stage company and we want to be careful about how much we say when we say it and so forth. So it's a little bit of a balance. But just because we haven't been communicating as frequently does not mean we are not working extremely hard. we're working very very hard the team is highly dedicated we are going to try and make more of a regular cadence of providing updates now that we're kind of closer to uh you know basically some of these big milestones we've described uh Ankush Sethi says, India is a huge market. Yeah, we agree. It is a huge market. What's the population of India right now? How many billions, Cameron, do you know?
It's one to one and a half billion.
There's a lot of people who need new replacements.
Yeah, but I think for India, not only population, but the level of sophistication of the surgeons over there and the health care, you know, and familiarity with new technologies with English. There are a lot of benefits to working with India, for sure.
What's nice about India, too, is the population is receptive to technology. They're they're not scared of robotics. yeah uh yeah it's uh angus uh who says you can do studies there too uh yeah we we think india is a pretty mature market for uh clinical studies okay somebody's asking so the greg saying you know so can you tell us what the foreign sale is being so again um uh in Pretty much. I mean, if there's a market in the world where you don't need to go through a regulatory process, please tell us. If you're from somewhere where Monochrome could just go and sell robots that are unapproved, we would like to know about it. But typically speaking, there's a regulatory process where to legally market your devices, and it doesn't matter where, it has to go through the proper channels, right? So what we have said is We have hired a CRO. We have found a distributor. We have found PIs, we have found sites, and we plan to hopefully initiate a clinical trial outside the US. So hopefully that's helpful context. Okay, so maybe we get one or two more last questions. Anybody have any other questions for the management team? Hopefully this was helpful. We appreciate everybody's time. I don't think a lot of public companies have this level of engagement, but we felt like it was really important to give our investors a chance to talk with us you know, one thing that I've always said this, right, is thank you for your support. We, you know, we really, really appreciate it. If your investment in Monogram is causing you stress, you're oversized, you know, use proper risk management. This is part of a diversified portfolio. I don't want anybody aping into this and going all in. That's not what this presentation is about. We want people to be conservative, cautious. If you want to be supportive of the technology, we appreciate it, but don't put your life savings into Monogram. Please do not do that. Just support us with whatever you have and Even if you have nothing, follow the story, share Monogram's technology, keep folks updated on what we're up to. I do see people who seem very distressed. You're probably over-positioned if you're distressed about your investment in Monogram. Great. Okay. We really appreciate everybody. Thank you so much for sticking with us. And we hope to do these with a more regular cadence. Looks like we got a lot of folks who stuck with us the whole, the whole thing. So that's great. We really appreciate your support and we hope to speak again with you soon. So thanks everybody. Really appreciate it. Thanks so much. follow the story, share Monogram's technology, keep folks updated on what we're up to. So I do see people who seem very distressed. You're probably over-positioned if you're distressed about your investment in Monogram. Great. Okay, we really appreciate everybody. Thank you so much for sticking with us. And we hope to do these with a more regular cadence. And so we look at a lot of folks who stuck with us the whole the whole thing. So that's great. We really appreciate your support. And we hope to speak again with you soon. So thanks, everybody. Really appreciate it. Thanks so much.